Precision PET Imaging for Neurodegenerative Diseases

CereMark Pharma™ is committed to developing innovative new PET imaging radiopharmaceuticals that bring highly precise visibility into the progression of neurodegenerative diseases in living brains.

Bringing Hope to Patients

Neurological diseases are a leading cause of disability and death worldwide, according to the World Health Organization, with Alzheimer’s disease (AD) and Chronic Traumatic Encephalopathy (CTE) being the most common forms of neurodegeneration. To date, there are no radiopharmaceuticals approved by the FDA that can differentiate whether individuals with Mild Cognitive Impairment (MCI) will develop further neurodegeneration. The need, therefore, is a method to predict the likely course of disease development in the early stages when patient management and treatments can be most effective. 

Improving the Detection of Neurodegenerative Pathology

Research involving CereMark Pharma’s novel investigational PET imaging biomarker F-18 Flornaptitrilalso known as F-18 FNTconfirms its uptake by both tau protein aggregates and beta-amyloid plaques that are associated with AD and CTE, thus enabling healthcare professionals to see the presence, distribution patterns and densities of these proteins in living brains. CereMark Pharma’s team of renowned medical, academic and radiopharmaceutical experts are working diligently towards the requisite clinical trial for FDA approval.

Causes of Neurodegeneration

Sadly, people with degenerative brain diseases have been described by many labels over the years, including that they are senile, forgetful, punch-drunk, dazed and absent-minded. Unfortunately, what lies behind these descriptions may be life-threatening diseases that annually impact millions of people this way. CereMark Pharma’s research and development efforts are focused on two of these forms of neurodegeneration: AD and CTE.

As highlighted below, AD is impacting millions of Americans. However, society and healthcare have only recently recognized the link between traumatic brain injuries that occur in professional and amateur sports, lifestyle recreational choices, military service and training, and accidents that are increasingly associated with CTE. This is important to note because the management of neurodegeneration, whether due to disease (AD) or an outcome of brain injury (CTE), can differ significantly. That’s why doctors and clinicians are eager for promising new tools like F-18 Flornaptitril, so they can predict the development of these two diseases more effectively in their early stages and improve patient management and outcomes.


According to disease forecasting by the CDC and Alzheimer’s Association, over 6 million Americans are living today with AD. Additionally, another 6+ million individuals have symptoms of mild cognitive impairment without dementia. The US demographics for AD have been shifting due to generational aging resulting in larger numbers of older adults and a greater prevalence of AD. 

Trauma from Domestic Abuse

The National Coalition Against Domestic Violence reports that over 10 million adults in the U.S. experience domestic violence every year. While a disproportionate number of adult women are victims, adult men and children can be victims of severe physical violence that causes injury. Whenever facial injuries occur, which happens to 80% of female victims, research suggests that there is a greater risk of TBI.

Concussive Brain Trauma from Sports Injuries

In the U.S., there are an estimated 300,000 diagnosed sports and recreation-related concussions annually, with a possibility of seven times more going undiagnosed. Additionally, the CDC estimated that there are 1.7 to 3.8 million TBIs each year. These injuries are often sustained from activities like cycling, football, playground equipment, basketball and exercise/equipment. 

Percussive Brain Trauma in Military Service

TBI associated with percussive (“blast-wave”) injuries that occur on the battlefield and during training, is increasingly associated with declining mental health. Estimates are that 20% of all veterans from the Iraqi and Afghan wars suffered percussive TBI. Research has shown percussive brain injuries result in brain damage, much like it occurs in concussive TBI.

Concussive Trauma from Accidents

The leading causes of TBI-related emergency room visits include accidents associated with falls, being struck by an object and motor vehicle crashes. Research has even linked moderate and severe TBI to a greater risk of developing Alzheimer’s disease or other neurodegenerative diseases years after the injury. The Alzheimer’s Association estimates that over 750,000 older adults are living with TBI-related disability. 

CereMark Pharma is in the process of initiating clinical trials on F-18 Flornaptitril, its investigational new drug, that are aimed at providing precise imaging of the brain pathology in mild cognitive impairment in individuals suspected to have either AD or CTE as may occur either from percussive or concussive brain trauma.